Print ISSN: 2319-2003 | Online ISSN: 2279-0780 IJBCP International Journal of Basic & Clinical Pharmacology

DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20194789 Original Research Article Assessment of knowledge, attitudes and practice among interns about over the counter drugs in a tertiary care hospital in India

Sudipto Chatterjee, R. Vijendra*, K. Girish, Mahesh Kumar Manjeri Koroth

Department of Pharmacology, Kempegowda Institute of ABSTRACT Medical Science, Bangalore, India Background: Drugs that are dispensed against a valid prescription issued to a patient by a registered medical practitioner are known as “prescription-only Received: 18 September 2019 drugs”. In India, they have been regulated under schedule H, H1, G, and X of Revised: 11 October 2019 the Drugs and Rules (1945). The drugs which are not included in the list of Accepted: 14 October 2019 “prescription-only drugs” are considered to be over-the-counter drugs (OTC). There is no provision for an OTC drug schedule in the Drugs and Cosmetics *Correspondence to: Rules 1945, and these drugs have higher chances of misuse or abuse. This study Dr. R. Vijendra, was undertaken to assess the knowledge, attitudes and practice among medical Email: vijendra_ramaiah@ interns about OTC drugs in a tertiary care hospital in India. yahoo.co.in Methods: This was a cross-sectional study, which was conducted at Kempegowda Institute of Medical Sciences and Research Center, Bangalore, Copyright: © the author(s), Karnataka, India, from March 2018 to September 2018. A pre-validated publisher and licensee Medip questionnaire consisting of 24 questions to assess the knowledge, attitude, and Academy. This is an open- practice was administered to 80 medical interns chosen by simple access article distributed under randomization, out of which 14 questions were related to knowledge, 6 related the terms of the Creative to attitude and 4 related to the practice. The participants were provided 30 Commons Attribution Non- minutes to complete the questionnaire. The data recorded were analyzed using Commercial License, which Microsoft Excel. permits unrestricted non- Results: There were some gaps in the knowledge, attitude and practice among commercial use, distribution, the medical interns about OTC medications. and reproduction in any Conclusions: There is a need for special emphasis on the MBBS curriculum medium, provided the original about the use of OTC drugs. work is properly cited. Keywords: Attitude, Knowledge, Practice, OTC drugs, Interns

INTRODUCTION and in the case of substances specified in Schedule X, the prescriptions shall be in duplicate, one copy of which Over-the-counter (OTC) medications are non-prescription shall be retained by the licensee for a period of two medications, i.e., these medications can be sold directly years”. to a consumer without a prescription from a qualified and registered healthcare professional.1 Most of the drugs are The Drugs and Cosmetics Rules (1945) classify drugs sold by a retail pharmacist only against a prescription of a into different schedules providing guidelines for storage, registered medical practitioner. These are “prescription- sale, display and prescription of drugs under each only drugs”, and in India, they have been placed in schedule. The major schedules include: Schedule H, H1, G, and X of the Drugs and Cosmetic Act (1940). Schedule G

Drugs and Cosmetics Act (1940) states “substances Includes hormonal and anti-hormonal, anti-diabetic, anti- specified in Schedule H and Schedule H1 or Schedule X neoplastic agents, etc., e.g., metformin, aminopterin, l- shall not be sold by retail except on and in accordance asparaginase, bleomycin, busulphan. with the prescription of a registered medical practitioner

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Schedule H METHODS

Drugs are to be sold by retail on the prescription of a This was a cross-sectional study, which was conducted at registered medical practitioner only. Majority of the Kempegowda Institute of Medical Sciences and Research prescription drugs are included in this schedule. Center (KIMS and RC), Bangalore, Karnataka, India, Presently, there are 536 drugs included in this schedule. from March 2018 to September 2018. A questionnaire E.g., allopurinol, colchicine. was prepared which consisted of 24 questions. Among them, 14 were related to the knowledge, 6 were related to Schedule H1 attitude and the remaining 4 questions were related to the practice aspects.4 This was validated by logical Include drugs which need to be very judiciously in order validation. The study was commenced after obtaining to prevent misuse and/or prevent development of drug approval from the KIMS institutional ethics committee. resistance. The Government of India on August 30, 2013, The questionnaires were administered to the consenting had made an amendment to the Drugs and Cosmetics Act participants- 80 medical interns of KIMS and RC, of 1940 and introduced the Schedule H1. Drugs included Bangalore. Approximately, 30 minutes were provided to under this schedule are antimicrobial agents including the participants for filling up the questionnaires. The data antitubercular drugs and such other drugs which should were analyzed using Microsoft Excel. be used sparingly in the general population. The details of the drugs should be recorded in a separate register at the time of the supply by the pharmacist mentioning the Questionnaire based cross-sectional study name and address of the prescriber, along with the name of the patient and the name of the drug with the quantity supplied. E.g., alprazolam, doripenam, balofloxacin, IEC clearance ertapenem, buprenorphine, capreomycin, ethionamide, cefdinir, feropenam, cefditoren.

Schedule X Conducted at KIMS and RC, Bangalore

Include those drugs where the retailer should preserve the prescription for a period of two years. It includes Sample size: 80 controlled drugs and drugs which have high likelihood of abuse and misuse. E.g., amobarbital, glutethimide pentobarbital, ketamine hydrochloride, amphetamine, meprobamate, phencyclidine, barbital, 24 questions: methamphetamine. Knowledge-based (14) Attitude-based (6) The Drugs and Cosmetics Rules (1945) also mandates Practice-based (4) that the drug label should contain the texts “Rx” in case of a Schedule H drug; “NRx” in case where the drug falls under the Narcotic Drugs and Psychotropic Substances Act, 1985; and “XRx” in case of a Schedule H drug. Time provided to participants (30 minutes) These labels shall be in red conspicuously displayed on the left top corner of the label.2

Currently, there is no OTC drug schedule in the Drugs Data captured in MS Excel and Cosmetics Act. As of now, drugs which are outside schedule H, H1, G, and X are considered to be an OTC 3 drug. The likelihood of misuse of drugs is, therefore, Analysis of the data 4 more with the OTC drugs.

Some essential characteristics of OTC drugs includes Figure 1: Methodology. high margin of safety and effectiveness, low potential for misuse and abuse, useful for self-diagnosable, conditions The questionnaire was framed to elicit the knowledge of and have adequate labeling for consumers.5 the participants (14 questions) including knowledge about the drug schedules, commonly used drugs such as Objectives analgesics, antimicrobials and sedatives, their appropriateness of usage, knowledge about drug The study was undertaken to assess the knowledge, interactions and adverse reactions and use of herbal drugs attitudes and practice among medical interns about OTC (Questions 1 to 14). It also included questions to elicit drugs in a tertiary care hospital in India. their attitude including concern of misuse of

International Journal of Basic & Clinical Pharmacology | November 2019 | Vol 8 | Issue 11 Page 2486 Chatterjee S et al. Int J Basic Clin Pharmacol. 2019 Nov;8(11):2485-2489 antimicrobial drugs, self-medication, and updating their schedule under the Drugs and Cosmetics Act. Knowledge knowledge of OTC medications (Questions 15 to 20). about some common drugs (alprazolam and levofloxacin) The practice-based questions elicited information included under Schedule H1 was inadequate. Knowledge regarding how they updated their information regarding about the dangers (GI perforation) of commonly used OTC drugs, how they dealt with misuse and abuse of the sodium bicarbonate containing antacids was lacking in OTC drugs and the sources for obtaining information many respondents (n=45; 55.13%). A must known fact about OTC drugs (Question 21 to 24). about dangers of aspirin use in children (Reye’s syndrome) was also lacking in many respondents (n=31; RESULTS 37.97%). Only 68.75% of respondents (n=55) believed that OTC drugs can cause severe adverse effects. The results of the study captured as responses to the questionnaire are depicted in the form of tables and Most of the respondents showed appropriate responses to graphs. questions regarding their attitude with regards to the OTC drugs (Table 2). Significant gaps also were present in the Table 1 indicates the correct responses to the questions attitude of the respondents regarding the appropriateness which elicited the understanding and knowledge of the of antimicrobials to be used as OTC agents (n=11; respondents about OTC drugs. Significant gaps were 13.75%), increased risk of self-medication with OTC noticed in the responses from the respondents with drugs (n=5; 6.25%). Attitude regarding putting an age bar regards to the knowledge about OTC drugs in India. Most for obtaining OTC drugs (n=5; 6.25%), potential for respondents (n=47; 58.75%) believed that “OTC drugs” misuse of OTC drugs (n=2; 2.50%) and restriction of had a legal backing in India, which is not true. “OTC OTC drugs (n=12; 15%) can be considered to be drugs” have not been defined or included in a separate inappropriate. Table 1: Knowledge-based questions.

Participants providing Sl. Correct Questions correct response No. response N (%) Schedule H, H1, G, X drugs can be given only with a 1 Yes 75 (93.75) prescription of a registered medical practitioner. 2 There is no legal recognition of OTC drugs in India. Yes 33 (41.25) 3 Alprazolam is in schedule H1. Yes 62 (80.52) 4 Levofloxacin is in schedule H. No 41 (53.95) 5 Morphine is an OTC drug. No 71 (88.75) 6 Paracetamol should not be used in jaundice. Yes 61 (76.25) 7 Aspirin should not be used in gastritis. Yes 71 (88.75) Sodium bicarbonate containing antacids has a risk of 8 Yes 35 (44.87) perforation in peptic ulcer patients. Prolonged use of a high dose of aspirin can cause analgesic 9 Yes 68 (85) nephropathy. 10 Aspirin should not be used in children. Yes 49 (62.03) 11 Antacids should not be used along with tetracyclines. Yes 50 (64.10) 12 OTC drugs can cause severe adverse effects. Yes 55 (68.75) 13 Fat-soluble vitamins can be used for prolonged periods. No 61 (77.22) 14 OTC herbal drugs can contain heavy metals. Yes 57 (72.15)

Table 2: Attitude based questions.

Participants providing Sl. Appropriate Questions appropriate response No. response N (%) 15 Do you think antimicrobials should be available OTC? No 69 (86.25) 16 Do you think OTC drugs lead to frequent self-medication? Yes 75 (93.75) 17 Should there be an age bar for obtaining OTC drugs? Yes 75 (93.75) Do you think it is necessary to periodically update 18 Yes 79 (98.75) information regarding OTC drugs? 19 Are you aware of the potential of misuse of OTC drugs? Yes 78 (97.50) 20 Do you think the use of OTC drugs should be restricted? Yes 68 (85.00)

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Table 3: Practice based questions.

Yes No Sl. No. Questions N (%) N (%) 21 Do you update your knowledge base about OTC drugs? 41 (51.25) 39 (48.75) 22 Do you buy OTC drugs without a prescription? 58 (73.42) 21 (26.58) Do you counsel others if you suspect any misuse/abuse of 23 75 (94.94) 4 (5.06) OTC drugs? Where do you get reliable information regarding OTC 24 Open ended question drugs?

Responses to questions revealing the practices of the Patil et al and Kasulkar et al in India which showed self- respondents with regards to OTC drugs are captured in medication is widely practiced among undergraduate 8,9 Table 3 and Figure 2. Nearly half of the respondents medical students. The most common drugs implicated (n=39; 48.75%) have failed to update their knowledge in self-medication include non-steroidal anti- about OTC drugs. Nearly a quarter of the respondents inflammatory drugs, antihistamines, gastrointestinal 10 (n=21; 26.58) have obtained OTC medication with a valid drugs, and antibiotics. Dangers with commonly used prescription. Majority of the respondents (n=75; 94.94%) OTC drugs such as NSAIDs such as an increased risk of have counselled people if they suspect any misuse or acute myocardial infarction occurring within one week of 11 abuse of OTC medications. The source of reliable use have to be highlighted. Another study found that information about OTC drugs in a significant number of NSAIDs were common medications responsible for self- 12 respondents (n=34; 42.5%) are from sources like the medication-related to cutaneous adverse drug reactions. internet. Information was obtained from medical literature (n=36; 45%) and from peers and professionals (n=11; The Government of India on August 30, 2013, had made 13.75%). an amendment to the Drugs and Cosmetics Act of 1940 and brought the schedule H1 notification, but to date, there is no separate OTC drug schedule in India.13 This 36 34 study reveals a gap in the knowledge, attitudes and practice among the medical interns about OTC drugs, which highlights the need for special emphasis in the undergraduate curriculum for medical students about OTC drugs. 11 CONCLUSION 1 There is a need for special emphasis and elaborate Medical Peers and Open source Do not know chapters in the MBBS curriculum about OTC drugs so literature Professionals that medical students are educated, empowered and

trained with necessary skills to tackle issues arising with Figure 2: Open ended practice based question about the use of OTC drugs. This emphasis will help the source of information about OTC drugs.* students to understand adverse drug reactions, their abuse, *Medical literature included medical books, pharmacopoeias, and misuse potential, potential drug-drug interactions and and medical journals. Peers and professionals included other other aspects of OTC drug use. medical practitioners and teachers. Open source included information from the internet and newspapers Funding: No funding sources Conflict of interest: None declared DISCUSSION Ethical approval: The study was approved by the Institutional Ethics Committee OTC medications are not always considered safe and beneficial for patients as they can be exposed to REFERENCES unexpected adverse drug reactions and drug-drug and drug-food interactions.6 OTC drugs can also have 1. Hanumantharayappa NB, Siddaiah SN. Use of over potential for their misuse and abuse such as codeine- the counter drugs in urban and rural populations of based medicines, cold and cough medications, sedative Mandya district: a cross-sectional study. Int J Basic antihistamines, decongestants and laxatives.7 Clin Pharmacol. 2016;5:1617-21. 2. The Drugs and Cosmetics Act and Rules. Available The dangers of self-medication are often underestimated, at: https://upload.indiacode.nic.in/showfile?actid= particularly with OTC drugs.3 Our study found that AC_CEN_12_13_00023_194023_1523353460112&t 73.42% of participants practice self-medication with ype=rule&filename=Drugs%20and%20Cosmetics%2 OTC drugs which was similar to one study conducted by

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